FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
K Number: K061877
·
Decision Sep 15, 2006
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
15
Applicant Total
432
Review Days
74
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Basic Information
- Device Name
- WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
- K Number
- K061877
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3610
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corp
- Date Received
- July 3, 2006
- Decision Date
- September 15, 2006
- Product Code
- MQR
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQR | Stent, Colonic, Metallic, Expandable | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQR), ordered by most recent decision date.
WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WallFlex Colonic Stent System with Anchor Lock Delivery System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANAROSTENT LowAx Colon/Rectum (NNN)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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